[S,S]-Reboxetine Add-On Trial

This study has been terminated.

( The DMC terminated the study on the basis of futility (insufficient clinical response). )

First Received: June 7, 2006 Last Updated: July 15, 2008 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00334685

Purpose

The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN

Condition	Intervention	Phase
Pain	Drug: [S,S]-Reboxetine	Phase II

Drug Information available for: Reboxetine Reboxetine mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	[S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin.

Further study details as provided by Pfizer:

Primary Outcome Measures:

The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 10 will be calculated

Secondary Outcome Measures:

The mean endpoint (week 10) sleep interference score change from baseline
Analysis of the Medical Outcomes Study Sleep Scale
Analysis of the Patient Global Impression of Change
Analysis of the Neuropathic Pain Symptom Inventory

Estimated Enrollment:	354
Study Start Date:	July 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have pain present for more than 3 months after the healing of shingles skin rash
Patients at screening must have a score >/=40 mm on the pain visual analogue scale

Exclusion Criteria:

Patients with significant renal and hepatic impairment
Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
Patients with clinically abnormal electrocardiogram

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334685

Show 83 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure )
Study ID Numbers:	A6061021
Study First Received:	June 7, 2006
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00334685 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuralgia, Postherpetic
Neurotransmitter Agents
Adrenergic Agents
Neuralgia
Psychotropic Drugs

Pregabalin
Pain
Antidepressive Agents
Reboxetine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Therapeutic Uses

Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents
Reboxetine

ClinicalTrials.gov processed this record on May 06, 2009